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Additional information
| Brand | Bionova |
|---|---|
| Process | Steam |
| Packaging | 200 (+) y 20 (-) |
| Microorganism | Bacillus subtilis (DSM 5230 – ATCC® 35021) |
| Population | 10^6 Spores/carrier |
| Read-Out Time | 48 h |
| Initial Color | Red |
| Final Color | Yellow |
| Regulations | IRAM 37102-1, IRAM 37102-3, ISO 11138-1, ISO 11138-3 |
| Volume | 0.6 ml |
| Length | 0.50 m |
| Field of activity | Pharmaceutical |
Description
BT24/6 / Self-contained Spore Ampoules for Industrial Steam low temperature sterilization of liquids (110° C- 121° C). Bacillus subtilis DSM 5230 (ATCC® 35021) 10^6 spores per ampoule. (7 x 40 mm). 0,6 ml of culture medium.
Bionova® BT24 Biological Indicator is specifically designed for monitoring of steam sterilization processes at 110 -121 ºC.
If the sterilization process was not successful, the indicator medium will turn to yellow after incubation between 35-39 ºC, thus indicating the presence of living Bacillus subtilis spores.
If the sterilization process was effective, the indicator medium will remain the original color after incubation. The final readout should be performed after 48 hours of incubation between 35-39 ºC.
Instructions for use
1. Take the Bionova® BT24 Ampoules out of the refrigerator and leave them at room temperature during not longer than ten minutes.
2. Place the Bionova® BT24 Ampoules inside a container with the liquid being sterilized or in a container with liquid similar to that containing the liquid to be sterilized. This container should be of the same size and have the same volume as the one containing the liquid being sterilized.
3. Sterilize as usual.
4. Once the sterilization process has finished, open the sterilizer door, wait five minutes and then remove the biological indicator from the container. WARNING: Wear safety glasses and gloves when removing the Bionova® BT24 Biological Indicator from the sterilized container.
5. Incubate the processed biological indicator, a negative control and a non-sterilized biological indicator as a positive control, during 48 hours between 35-39 ºC.
The positive control ensures that the incubation conditions were met.
The negative control, not being exposed to the sterilization process, can be used as a reference color to compare positive and negative results. Conversely, when used with the ampoules during the process, it ensures that any color change produced immediately after sterilization is the result of the process and not due to germination and/or spore growth.
Readout should be performed at convenient intervals of 10 hours.
It is recommended the use of Bionova® IC10/20 Dual Incubator or similar devices that assure an effective temperature control. WARNING: Traditional culture stoves have thermal profiles that differ from the above recommended incubators, thus their use might affect or delay the Bionova® BT21 Biological Indicators result.
A color change to yellow of the proccesed biological indicator medium means a sterilization process failure has occurred.
If after 48 hours there is no color change in the processed indicators, a final negative result is obtained, meaning the sterilization process was successful. The positive control indicator should turn to yellow for the result to be valid and the negative control should remain the same color.
Description
BT24/6 / Self-contained Spore Ampoules for Industrial Steam low temperature sterilization of liquids (110° C- 121° C). Bacillus subtilis DSM 5230 (ATCC® 35021) 10^6 spores per ampoule. (7 x 40 mm). 0,6 ml of culture medium.
Bionova® BT24 Biological Indicator is specifically designed for monitoring of steam sterilization processes at 110 -121 ºC.
If the sterilization process was not successful, the indicator medium will turn to yellow after incubation between 35-39 ºC, thus indicating the presence of living Bacillus subtilis spores.
If the sterilization process was effective, the indicator medium will remain the original color after incubation. The final readout should be performed after 48 hours of incubation between 35-39 ºC.
Instructions for use
1. Take the Bionova® BT24 Ampoules out of the refrigerator and leave them at room temperature during not longer than ten minutes.
2. Place the Bionova® BT24 Ampoules inside a container with the liquid being sterilized or in a container with liquid similar to that containing the liquid to be sterilized. This container should be of the same size and have the same volume as the one containing the liquid being sterilized.
3. Sterilize as usual.
4. Once the sterilization process has finished, open the sterilizer door, wait five minutes and then remove the biological indicator from the container. WARNING: Wear safety glasses and gloves when removing the Bionova® BT24 Biological Indicator from the sterilized container.
5. Incubate the processed biological indicator, a negative control and a non-sterilized biological indicator as a positive control, during 48 hours between 35-39 ºC.
The positive control ensures that the incubation conditions were met.
The negative control, not being exposed to the sterilization process, can be used as a reference color to compare positive and negative results. Conversely, when used with the ampoules during the process, it ensures that any color change produced immediately after sterilization is the result of the process and not due to germination and/or spore growth.
Readout should be performed at convenient intervals of 10 hours.
It is recommended the use of Bionova® IC10/20 Dual Incubator or similar devices that assure an effective temperature control. WARNING: Traditional culture stoves have thermal profiles that differ from the above recommended incubators, thus their use might affect or delay the Bionova® BT21 Biological Indicators result.
A color change to yellow of the proccesed biological indicator medium means a sterilization process failure has occurred.
If after 48 hours there is no color change in the processed indicators, a final negative result is obtained, meaning the sterilization process was successful. The positive control indicator should turn to yellow for the result to be valid and the negative control should remain the same color.
